Adjuvant Radiotherapy for Pathological T3N0M0 Prostate Cancer Significantly Reduces Risk of Metastases and Improves Survival: Long-Term Followup of a Randomized Clinical Trial
Received 15 September 2008 published online 23 January 2009.
Purpose
Extraprostatic disease will be manifest in a third of men after radical prostatectomy. We present the long-term followup of a randomized clinical trial of radiotherapy to reduce the risk of subsequent metastatic disease and death.
Materials and Methods
A total of 431 men with pT3N0M0 prostate cancer were randomized to 60 to 64 Gy adjuvant radiotherapy or observation. The primary study end point was metastasis-free survival.
Results
Of 425 eligible men 211 were randomized to observation and 214 to adjuvant radiation. Of those men under observation 70 ultimately received radiotherapy. Metastasis-free survival was significantly greater with radiotherapy (93 of 214 events on the radiotherapy arm vs 114 of 211 events on observation; HR 0.71; 95% CI 0.54, 0.94; p = 0.016). Survival improved significantly with adjuvant radiation (88 deaths of 214 on the radiotherapy arm vs 110 deaths of 211 on observation; HR 0.72; 95% CI 0.55, 0.96; p = 0.023).
Conclusions
Adjuvant radiotherapy after radical prostatectomy for a man with pT3N0M0 prostate cancer significantly reduces the risk of metastasis and increases survival.
cThe Fred Hutchinson Cancer Research Center, Seattle, Washington
dThe Kansas City Community Clinical Oncology Program, Kansas City, Missouri
eThe University of Colorado Health Science Center, Denver, Colorado
fThe James P. Wilmot Cancer Center, University of Rochester School of Medicine, Rochester, New York
gWayne State University School of Medicine, Detroit, Michigan
hUniversity of Western Ontario, Department of Surgical Oncology, London, Ontario
Correspondence: Department of Urology, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, Texas 78229 (telephone: 210-567-5643; FAX: 210-567-6868)
Study received approval from individual institutional review boards of the participating institutions.
Supported by Public Health Service Cooperative Agreement grants awarded by the National Cancer Institute, Department of Health and Human Services: CA38926, CA32102, CA14028, CA58416, CA58658, CA42777, CA27057, CA46136, CA35431, CA58882, CA12644, CA58861, CA35090, CA37981, CA76429, CA04919, CA76132, CA35119, CA35178, CA35176, CA46282, CA67575, CA45377, CA46113, CA74647, CA35261, CA049020, CA20319, CA76447, CA58723, CA12213, CA22433, CA46441, and by the National Cancer Institute of Canada Grant PR-2.
† Financial interest and/or other relationship with Veridex, Mission and AstraZeneca.
ABSTRACT